Needlescopic instrument with reusable handle and detachable needle assembly

ABSTRACT

A surgical device including a disposable needle assembly, a reusable handle assembly and a retractable slide. A method for inserting and releasing a disposable needle assembly from a reusable handle assembly is included. The handle assembly includes a ratchet mechanism, locking mechanism, arming mechanism and a cage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Stage of International patent applicationPCT/US2014/034397, filed on Apr. 16, 2014, which claims priority to U.S.provisional patent application No. 61/812,691, filed on Apr. 16, 2013,the disclosures of which are incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to surgical instruments and methods oftheir use, and more particularly, to minimally invasive surgicalinstruments incorporating a needle and a working tool disposed withinand configured to extend and retract from the needle tip.

Description of Related Art

Over the last two decades, minimally invasive surgery has become thestandard for many types of surgeries which were previously accomplishedthrough open surgery. Minimally invasive surgery generally involvesintroducing an optical element (e.g., laparoscopic or endoscope) througha surgical or natural port in the body, advancing one or more surgicalinstruments through additional ports or through the endoscope,conducting the surgery with the surgical instruments, and withdrawingthe instruments and scope from the body. In laparoscopic surgery(broadly defined herein to be any surgery where a port is made via asurgical incision, including but not limited to abdominal laparoscopy,arthroscopy, spinal laparoscopy, etc.), a port for a scope is typicallymade using a surgical trocar assembly.

The trocar assembly often includes a port, a sharp pointed element(trocar) extending through and beyond the distal end of the port, and atleast in the case of abdominal laparoscopy, a valve on the proximalportion of the port. Typically, a small incision is made in the skin ata desired location in the patient. The trocar assembly, with the trocarextending out of the port, is then forced through the incision, therebywidening the incision and permitting the port to extend through theincision, past any facie, and into the body (cavity). The trocar is thenwithdrawn, leaving the port in place. In certain circumstances, aninsufflation element may be attached to the trocar port in order toinsufflate the surgical site. An optical element may then be introducedthrough the trocar port. Additional ports are then typically made sothat additional laparoscopic instruments may be introduced into thebody.

Trocar assemblies are manufactured in different sizes. Typical trocarport sizes include 5 mm, 10 mm, and 12 mm, which are sized to permitvariously sized laparoscopic instruments to be introduced therethroughincluding, e.g., graspers, dissectors, staplers, scissors,suction/irrigators, clamps, forceps, biopsy forceps, etc. While 5 mmtrocar ports are relatively small, in some circumstances where internalworking space is limited (e.g., children), it is difficult to placemultiple 5 mm ports in the limited area. In addition, 5 mm trocar portstend to limit movement of instruments inside the abdominal cavity to agreat extent.

Further, while laparoscopic surgery has reduced the trauma associatedwith various surgical procedures and has concomitantly reduced recoverytime from these surgeries, there always remains a desire in the art tofurther reduce the trauma to the patient. One area of trauma associatedwith laparoscopic surgery identified by the inventor hereof as beingsusceptible of reduction are the scars which result from the trocarports used. In many laparoscopic surgeries, three or more trocarincisions are made. For example, in laparoscopic hernia repair surgery,four trocar incisions are typically made, with one incision forinsufflating the abdomen and inserting the optical device, two incisionsfor trocar ports for inserting graspers therethrough, and a fourth portfor passing a stapler therethrough. Those skilled in the art and thosewho have undergone surgical procedures are aware that even the 5 mmtrocar ports leave holes which must be stitched and which result inscars. Scar tissue may affect the internal portion of the facia as wellas the cosmetic appearance of the skin, which may be detrimental for thepatient or even a surgeon if that area of the skin is subject to a laterincision or medical procedure.

A second area of trauma associated with laparoscopic surgery relates totrauma resulting from the manipulation (e.g, angling) of the trocarports required in order to conduct the surgery due to inexact placement.Angling of the port can cause tearing at the incision periphery. Suchtearing can lead to extensive scar tissue and in general an extension ofthe incision area.

There continues to be a need in the art for lower cost laparoscopictools and surgical assemblies which have improved applications, reducetrauma to the patient, reduce complications to the patient, do not leadto extension of the incision area, do not lead to increased scar tissuegeneration, are easy to make and use, and improve safety while reducingcosts to health care providers and patients and reducing the surgicaltime for a procedure which in turn may reduce costs and complications.The inventive device includes a reusable handle assembly which can beactuated with various needle assemblies of varying diameters and endeffectors. Thus the same inventive device may have many different useswithin one surgical procedure. These and other needs are met by theinventive device and method.

Other advantages of the present invention will become apparent from thefollowing description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is one embodiment of an actuated device of the present inventionwith the graspers in a retracted position.

FIG. 2 is an embodiment of an unactuated device of the present inventionwith the graspers in an open position.

FIG. 3 is an embodiment of an actuated device of the present inventionwith the grasper in a closed position.

FIG. 4 is an embodiment of the reusable handle assembly of theunactuated device of the present invention.

FIG. 5 is an embodiment of the reusable handle assembly of the actuateddevice of the present invention.

FIG. 6 is an embodiment of the reusable handle assembly of a system ofthe actuated device of the present invention.

FIG. 7 is an embodiment of the reusable handle assembly of a system ofthe actuated device of the present invention.

FIG. 8 is an embodiment of an arm slide of the present invention.

FIG. 9 is an embodiment of a button assembly of the present invention.

FIG. 10 is an embodiment of the reusable handle assembly of the presentinvention.

FIG. 11 is an embodiment of the reusable handle assembly of the presentinvention.

FIG. 12A is a perspective of a cage assembly embodiment of the reusablehandle assembly of the present invention.

FIG. 12B is a side plan of a cage assembly embodiment of the reusablehandle assembly of the present invention.

FIG. 12C is a perspective of a cage assembly embodiment of the reusablehandle assembly of the present invention.

FIG. 13A is a perspective of a ratchet mechanism embodiment of thereusable handle assembly of the present invention.

FIG. 13B is a side plan of a ratchet mechanism embodiment of thereusable handle assembly of the present invention.

FIG. 14 is a side plan of a ratchet mechanism embodiment of the reusablehandle assembly of the present invention.

FIG. 15 is an exploded view of a ratchet mechanism embodiment of thereusable handle assembly of the present invention.

FIG. 16A is an embodiment of a lock pin of the present invention.

FIG. 16B is an embodiment of a lock pin of the present invention.

FIG. 16C is an embodiment of a lock pin of the present invention.

FIG. 16D is an embodiment of a lock pin of the present invention.

FIG. 17 is an embodiment of a lock pin of the present invention.

FIG. 18A is an embodiment of a monopolar arm slide of the presentinvention.

FIG. 18B is an embodiment of a monopolar arm slide of the presentinvention.

FIG. 19A is an embodiment of a cap on a disposable needle assembly ofthe present invention.

FIG. 19B is an embodiment of a cap on a disposable needle assembly ofthe present invention.

FIG. 19C is an embodiment of a cap on a disposable needle assembly ofthe present invention.

FIG. 19D is an embodiment of a cap on a disposable needle assembly ofthe present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made to the drawings wherein like referencenumerals identify similar structural features or aspects of the subjectinvention. For purposes of explanation and illustration, and notlimitation, exemplary embodiments of a minimally invasive surgicalassembly in accordance with the invention, or aspects thereof, are shownin FIGS. 1-19D. The surgical assembly of the invention is a low cost,easy to manufacture, medical device which can be used, for example,during minimally invasive surgical procedures to reduce trauma to apatient.

Examples of minimally invasive surgical assemblies and related equipmentare described in U.S. Pat. No. 7,766,937 to Ravikumar, U.S. Pat. No.8,230,863 to Ravikumar et al., U.S. Pat. No. 8,313,507 to Ravikumar,U.S. Pat. No. 8,133,255 to Ravikumar et al., U.S. patent applicationSer. No. 11/685,522 to Ravikumar et al (published as U.S. Patent Pub.No. 2007/0250112), U.S. patent application Ser. No. 12/503,035 toRavikumar (published as U.S. Patent Pub. No. 2010/0016884), U.S. patentapplication Ser. No. 12/689,352 to Ravikumar et al (published as U.S.Patent Pub. No. 2010/0292724), U.S. patent application Ser. No.11/610,746 to Ravikumar et al (published as U.S. Patent Pub. No.2007/0282170), and U.S. patent application Ser. No. 12/689,352 toRavikumar et al (published as U.S. Patent Pub. No. 2010/0292724), all ofwhich patents, applications, and publications are incorporated byreference herein in their entireties.

Referring now to FIG. 15, a surgical device 100 is shown which includesa disposable needle assembly 110 and two embodiments of a reusablehandle assembly 150 operatively associated therewith. FIGS. 1 and 3 showone embodiment of the reusable handle assembly 150 while FIGS. 2, 4, and5 show another embodiment of the reusable handle assembly 150. Ingeneral, the reusable handle assembly 150 is preferably configured andadapted to receive the disposable needle assembly 110, manipulate itduring a surgical procedure, and release it for disposal.

The disposable needle assembly 110 is preferably configured and adaptedto be advanced into the reusable handle assembly 150, set into position,and operated for one time use. The disposable needle assembly 110 isalso preferably configured and adapted to prevent reprocessing thereofonce used, and may be provided with a 2.4 mm needle or a 5 mm needle.The reusable handle assembly 150 is preferably configured and adapted toreceive, operate, and release the disposable needle assembly 110regardless of whether a 2.4 mm needle is provided for insertionpercutaneously under direct visualization without the use of a trocar,or whether a 5 mm needle is provided for use with a trocar duringlaparoscopic procedures. In this manner, the surgical device 100 allowsfor improved management and control of the assemblies thereof, reducescosts to health care providers, and prevents unauthorized reprocessingand selling of needle assemblies without MLT certification.

As shown in FIG. 1, disposable needle assembly 110 includes an elongatedneedle member 112, a needle hub 114 which detachably couples and islongitudinally fixed to the handle assembly 150, and a grasping assembly116 operatively associated with a lumen 113 defined by elongated needlemember 112. Elongated needle member 112 and grasping assembly 116 areselectively longitudinally translatable relative to one another andrelative to needle hub 114 and handle assembly 150 via user manipulationof handle assembly 150.

Elongated needle member 112 includes a sharpened distal tip portion 118,a needle shaft 119 having an inner surface which defines lumen 113through which grasping assembly 116 longitudinally translates. Needleshaft 119 extends through a lumen 120 defined by needle hub 114, andinto the interior of the handle assembly 150 as shown in FIG. 6.Continuing with FIG. 6, needle shaft 119 of needle member 112 extendsthrough proximal and distal portions 114 a, 114 b of needle hub 114, andcouples to proximal member 130. Proximal member 130 has a proximal head115 of enlarged diameter which interfaces to sliding shaft 122 of thehandle assembly 150. As shown, sliding shaft 122 is coupled to a trigger158 of handle assembly 150. In this manner, trigger 158 is retractableto distally longitudinally translate sliding shaft 122 of handleassembly 150 and proximal member 130 of needle member 112 relative tograsping assembly 116.

As shown in FIG. 1, grasping assembly 116 includes a pair of endeffectors (e.g., upper and lower arms) 124, 126 coupled to or integrallyformed with a shaft 128 having an outer surface profile corresponding tothe inner surface of the needle shaft 119. Upper and lower arms 124, 126are preferably biased radially outward from the longitudinal axis ofshaft 128, but can also be provided as one or more hinged jaws or othersurgical tools such as those described in the above referenced patentsand publications incorporated by reference herein. Shaft 128 extendsthrough lumen 113 along the length of the needle shaft 119, throughneedle hub 114, and into the interior of the handle assembly 150 asshown in FIG. 6. Shaft 128 of grasping assembly 116 is coupled to aproximal member 130 having a proximal end 132. Proximal member 130 isselectively longitudinally translatable within the lumen 113 ofelongated needle member 112, and within the sliding shaft 122 of handleassembly 150 via user manipulation of a retractable slide of the handleassembly 150 (further discussed below). The retractable slide of thehandle assembly 150 interfaces to proximal end 132 to translate shaft128 and arms 124, 126 of grasping assembly 116 relative to elongatedneedle member 112.

Proximal member 130 preferably has a cross-section which defines aninterference fit with interior surfaces of the lumen 113 of elongatedneedle member 112 to rotatably fix elongated needle member 112 tograsping assembly 116. For example, the lumen 113 may define arectangular cross section and proximal member 130 may also define arectangular cross section along at least a portion thereof which canlongitudinally translate within proximal member 130, yet which cannotrotate relative thereto. Needle hub 114 also preferably defines lumen120 in a manner which allows longitudinal translation of needle shaft119 relative to needle hub 114, yet which rotatably fixes needle hub 114to needle shaft 119. Certain embodiments of such rotational limits areshown in FIGS. 10 and 12A.

As further discussed below with respect to the handle assembly 150, suchstructure facilitates rotation of needle member 112, needle hub 114, andgrasping assembly 116 together independent of handle assembly 150, aswell as longitudinal advancement of the needle member 112 over thegrasping assembly 116, all by user manipulation of handle assembly 150.

As shown in FIGS. 1-5, handle assembly 150 includes a housing 152 forstoring and protecting the components thereof, a rotation hub 154 forrotating the elongated needle member 112, needle hub 114, and graspingassembly 116, and a proximal handle member 156, a distal trigger 158,and a drive link 160 for actuating distal longitudinal translation ofthe elongated needle member 112 relative to the grasping assembly 116.Such distal translation causes the disposable assembly 110 to move fromthe open configuration shown in FIG. 1 to the closed configuration shownin FIG. 5 as the needle member 112 is forced over at least a portion ofthe arms 124, 126. The grasping assembly 116 may further be covered bythe needle or sharpened distal tip portion 118 as shown in FIG. 3.

FIGS. 1-5 also show the grasping assembly 116 in different stages ofactuation. In FIG. 1 the grasping assembly has open arms 124, 126compared to FIG. 2 where arm 124 is open but arm 126 is semi-closed andcompared to FIG. 5 where arms 124, 126 are closed but the distal tip 118of the needle has not been pushed over the grasping assembly 118 suchthat in use the grasping assembly 118 is grasping a material such astissue, a blood vessel or organ.

Continuing with FIG. 6, handle assembly 150 further includes a crankassembly 162 for coupling trigger 158 to sliding shaft 122 of handleassembly 150, and a primary return spring 164 for biasing sliding shaft122 proximally and trigger 158 distally toward the configuration of FIG.2 in which the arms 124, 126 of the grasping assembly 116 are extendedrelative to the needle member 112 and open. Handle assembly 150 alsoincludes an arm slide 166 for manipulating elongated needle member 112,a secondary return spring 168 for biasing arm slide 166 distally towardthe position shown in FIG. 7 (which corresponds to the configuration ofFIG. 2). Handle assembly 150 also includes a release lever 170 forallowing release of disposable needle assembly 110 from handle assembly150, and a latch assembly for receiving, positioning, operating, andreleasing elongated needle member 112 from handle assembly 150. Thelatch assembly includes latches 174 a, 174 b, 174 c, and release bar176, which, in conjunction with release lever 170, operate to verticallyraise and lower latches 174 a, 174 b, 174 c to receive and release thedisposable assembly 110. The release lever does not need to move toreceive a disposable assembly.

More particularly, latches 174 a, 174 b, 174 c respectively couple toproximal end 132 of proximal member 130 of grasping assembly 116,proximal end 115 of proximal member 113 of elongated needle member 112,and an intermediary member 121 coupled to and disposed between shaft 119and proximal member 113 as shown. Release bar 176 defines horizontalgrooves 178, 180, 182 which receive respective pins 184, 186, 188 (FIG.8) of latches 174 a, 174 b, 174 c to allow longitudinal translation ofthe latches in their respective grooves. Release bar 176 also definesvertical grooves 190, 192 which receive pins 191, 193 connected tohousing 152. Pins 191, 193 substantially constrain movement of releasebar 176 to the vertical direction relative to housing 152, and alsorestrict the extent of such vertical movement as shown.

Turning to FIGS. 6 and 16A, assembly of one embodiment of the surgicaldevice 100 occurs as follows. Proximal member 130 of disposable needlemember 112 is advanced into an aperture (not shown) in rotation hub 154and into the interior of the housing 152 via aperture 153. Proximal end132 encounters latch 174 c, which rotates clockwise (as sloped surface175 is pushed upward by proximal end 132) to allow entry of proximalmember 130. It will be appreciated that release bar 176 is biased upwardby vertical spring 177, which biases latches 174 a, 174 b, 174 c towardcounter clockwise rotation toward their original position when they arerotated clockwise. Proximal end 132 is fed through sliding shaft 122 ofhousing assembly 150, and advanced proximately until it reaches distalend 155 of retraction slide 166, which is operatively disposed in aforward position as shown in FIG. 6. When proximal end 132 reachesdistal end 155 of retraction slide 166, it clicks into place betweendistal end 155 and latch 174 a as latch 174 a closes around the enlargedhead thereof.

It will be appreciated that when proximal end 132 of proximal member 130of grasping assembly 116 reaches distal end 155 of retraction slide 166,the radially enlarged head 117 of proximal member 113 of elongatedneedle member 112 interfaces to sliding shaft 122 of handle assembly150, and also snaps into place between latch member 174 b and slidingshaft 122. In this manner, both the inner grasping assembly 116 andouter needle member 112 are positioned and operatively coupled to handleassembly 150 for independent control thereof. The assembledconfiguration of FIG. 6 corresponds to that shown in FIG. 5, in whichthe arms 124, 126 of the grasping assembly 116 are exposed and act as anobturator relative to the distal tip 118 to help prevent accidentaltrauma with the distal tip 118. In this configuration, trigger 158 hasbeen pulled back and ratcheted in place via ratchet 159 to keep arms124, 126 in a closed position. It is anticipated that the surgicaldevice 100 could be shipped in this configuration with one disposableneedle assembly 110 already assembled therein. Alternatively oradditionally, the surgical device 100 could be shipped with a singlehandle assembly 150 and one or more separate disposable needleassemblies 110 separately contained in the same or different packaging.

Returning to FIG. 6 with continued reference to FIGS. 2, 4, 5 and 9,operation of one embodiment of the device 100 occurs as follows. Button194 (best shown in FIG. 9) is depressed by a user (e.g., a surgeon),causing rim 194 a to deploy from groove 195 defined in retraction slide166 to ride along edge 181 of retraction slide 166. Retraction slide 166may then be pulled proximally against the bias of spring 168 until rim194 a reaches secondary groove 197 and snaps therein. This motion pullsslide 166 to the retracted position of FIG. 4, which directly pulls arms124, 126 of grasping assembly 116 fully into needle member 112 to exposedistal tip 118 as shown in FIG. 1. At this point, the device is armed,and the distal tip 118 is advanced into the patient to a surgical site.Once the surgical site is reached, button 194 is depressed, and spring168 pulls slide 166 back to the forward position of FIG. 7, whichcorresponds to the advanced open configuration of the arms 124, 126 inFIG. 2. Rotation hub 154 may be utilized to rotate grasping assembly 116and needle member 112 as needed independent of housing assembly 150, andthe entire assembly may additionally be manipulated by the surgeon asneeded to establish a desired orientation of arms 124, 126 about targettissue in the patient. Finally, ratchet 159 is disengaged, and trigger158 is pulled to distally advance sliding shaft 122, and thus needlemember 112 over the grasping assembly 116 to close and clamp arms 124,126 about the target tissue. It will be appreciated that arms/jaws 124,126 remain in a fixed longitudinal position relative to the patientduring closing thereof, which can be advantageous to the surgeon toavoid unwanted motion or displacement.

Once the elongated needle member 112 is removed from the patient,release lever 170 (FIGS. 6, 8) is operated to vertically raise releasebar 176, which vertically raises latches 174 a, 174 b, 174 c to provideclearance for removal of disposable needle assembly 110 through aperture153. Disposable assembly 110 (FIG. 16A) is pulled distally throughaperture 153 (FIG. 7) for removal and discarding thereof. A newdisposable assembly can subsequently be used with the reusable handleassembly 150. The handle assembly 150 may be steam sterilized orsterilized through any other suitable and appropriate manner known inthe art.

Turning now to FIGS. 16A-16D, in one embodiment of the invention, thedisposable needle assembly 110 includes a push button assembly 200 andassociated structure which prevents longitudinal translation of graspingassembly 116 relative to needle member 112 when button 201 isoperatively disposed in an unpressed radially outward configuration. Asshown, push button 201 is configured and adapted to be radiallytranslated from the radially outward position to a radially inwardposition. In the radially outward position, flanges 202, 204 interfaceto shaft 128 (e.g., via interference fit) of grasping assembly 116 toprevent distal longitudinal translation of shaft 128 relative to shaft119 of elongated needle member 112. As shown in FIG. 16B, button 201defines a cutout 206 situated to provide a passage for longitudinaltranslation of shaft 128 when button 201 is depressed into the radiallyinward position. Button 201 preferably extends into needle hub 114, anddefines an arcuate outer surface 208 which is radially aligned with orradially inward of outer surface 123 of needle hub 114 when button 201is depressed to the radially inward position. Additionally, side surface211 of button 201 preferably forms an interference fit with innersurface 210 (FIG. 16A) of needle hub 114 such that significant pressureis needed to depress button 201. In this manner, once depressed, button201 becomes stuck in the depressed position and cannot be moved radiallyoutward because all surfaces thereof are firmly wedged within needle hub114.

It will be appreciated that button assembly 200 prevents needle assembly110 from accordion folding when inserted into reusable handle assembly150 (e.g., prevents grasping assembly 116 and components thereof fromtranslating distally relative to elongated needle member 112 whendisposable needle assembly 110 is inserted into handle assembly 150). Itwill also be appreciated that once disposable needle assembly 110 isinserted into handle assembly 150, button 201 may be depressed to allowdistal translation of grasping assembly 116 to operate the device 100.

Button assembly 200 also functions to help prevent unauthorized re-use,re-selling, or replication of disposable needle assembly 110 by virtueof the inability to longitudinally lock the components of the needleassembly 110 (e.g., for loading the needle assembly 110 into the handleassembly 150) once button 200 is pushed, and the inability to take apartdisposable needle assembly 110.

It will be appreciated that the internal mechanisms of the handleassembly 150 described above may alternatively be accomplished using amore simplified structure having less moving parts. For example,elongated needle 112 may be configured as one integrated piece ofuniform diameter extending from distal tip 118 to proximal end 115, andgrasping assembly 116 may similarly be configured as one integratedpiece extending from arms 124, 126 to proximal end 132. For example, oneor two latches may be utilized instead of three, and structure differentfrom the latches and sliding shaft disclosed above may be utilized tointerface to elongated needle 112 and grasping assembly 116.

Turning to FIG. 17, a disposable needle assembly 310 is shown whichincludes a conventional 5 mm device. Disposable needle assembly 310includes a shaft 319 configured to be inserted through a standardtrocar, hub assembly 314 configured and adapted to be coupled andlongitudinally fixed to housing assembly 150, and proximal inner shaft330 which longitudinally translates within shaft 319 and hub assembly314. As shown, inner shaft 330 contains a radially enlarged rim 335which couples to sliding shaft 122 of housing assembly 150. In thismanner, trigger 158 of housing assembly 150 may be utilized to directlytranslate the inner rather than the outer components of the disposableassembly. In such 5 mm embodiments, it will be appreciated that shaft319 is longitudinally fixed to hub assembly 314, and that only innershaft 330 moves relative thereto. Button assembly 200 is preferablyprovided to disposable needle assembly 310 in order to preventlongitudinal translation of the components thereof during loading intohousing assembly 150 as discussed above.

A further embodiment of the handle assembly 150 of the present inventionis shown in FIGS. 10-15. FIGS. 10 and 11 show two sides of a furtherembodiment of the handle assembly 150 of the present invention whereinthe trigger motion of the trigger 158 when compressed causes arotational motion of the crank assembly 162 which causes linear motionof the elongated needle member 112. In this embodiment the trigger 158is of different configuration than that shown in FIGS. 6 and 7. In FIGS.10 and 11 trigger 158 is of an open trigger with movement limited by atrigger lock (shown in FIGS. 12A and 12B). The trigger lock 340 includesa trigger lock link 346 and rotational lock such that when the button201 is pushed inward by the user (e.g., surgeon) the trigger lock 340locks in the trigger 158 in a depressed state with the grasping assembly116 in a closed position. The handle assembly includes a cage comprisedof a right cage 360 and left cage 361 which defines the inner workingsof the handle assembly 150.

Continuing with FIGS. 10 and 11, handle assembly 150 further includes aprimary return spring 164 for biasing sliding trigger 158 distallytoward the configuration of FIG. 1 in which the arms 124, 126 of thegrasping assembly 116 are extended relative to the needle member 112 andopen. Handle assembly 150 also includes an arm slide 166 formanipulating elongated needle member 112. Handle assembly 150 alsoincludes a release switch 175 and release spring 171 for allowingrelease of disposable assembly 110 from handle assembly 150 and a latchassembly for receiving, positioning, operating, and releasing elongatedneedle member 112 from the guide box 179 within handle assembly 150. Theguide box 179 is configured to match the configuration of the proximalmember 130 of the disposable needle assembly 110 such as, for example,both the guide box 179 and proximal member 130 being configured in theshape of a rectangle or square or circle or oval or any othercorresponding geometric shape.

As shown in more detail in FIGS. 12A and 12B, the latch assemblyincludes latches 174 d and 174 e, which are found on right cage 360, andrelease bar 176, which, in conjunction with release spring 171, operateto vertically raise and lower latches 174 d and 174 e to receive andrelease the disposable assembly 110. Release bar 176 defines horizontalgrooves 178 and 180 which receive respective pins 184 and 186 of latches174 d and 174 d to allow longitudinal translation of the latches intheir respective grooves. As shown in FIG. 14, release bar 176 on rightcage 360 also defines vertical grooves 190, 192 which receive pins 191a, 191 b, 193 a and 193 b connected to housing 152. Pins 191 a, 191 b,193 a and 193 b substantially constrain movement of release bar 176 tothe vertical direction relative to housing 152, and also restrict theextent of such vertical movement as shown.

The handle assembly 150 includes a ratchet mechanism so as to preventtrigger and needle return throughout the full jaw closure stroke. In oneembodiment the ratchet mechanism has audible and tactile clicks duringactuation. The ratchet mechanism may have a number of lock positions andin one embodiment has a minimum of nine (9) lock positions throughoutthe full jaw closure stroke. The final ratchet position may correspondwith the fully closed jaw safe position. Turning to FIGS. 10, 13A, 13Band 15, a ratchet 159 is shown as activated by a ratchet switch 157. Theratchet switch 157 allows the ratchet mechanism to be turned on and offto disengaged the ratchet and allow free opening of the jaws upon manualrelease of the trigger 158. The ratchet switch 157 is found on bothsides of the handle assembly 150 and may be actuated by the thumb of theuser. The up switch position corresponds with the ratchet mode, the downposition corresponds to the free mode. The switch shaft 161 is connectedto the switch spring level 163 activated by the switch link 165 andswitch spring 167. The ratchet spring 169 is connected to the ratchetswitch 157. A switch spring 167 drives the switch to its final ratchetor free positions to prevent the switch from residing in an intermediateposition. Switch actuation will have an audible and tactile click whenin use. A temporary ratchet release trigger resides forward of the maintrigger and is to be actuated by the index finger. The temporary releasetrigger allows the ratchet to be released when it is squeezed when thedevice is in the ratchet mode. It will have a spring return and willreengage the ratchet when it is released.

Another feature of this embodiment of the handle assembly 150 of thepresent invention is the rotational hub 154. When the proximal member130 of disposable elongated needle member 112 is advanced into anaperture (not shown) in rotation hub 154 and into the interior of thehousing 152 via the guide box 179 there is a rotation detent spring 151which provides an audio cue to the user (e.g., surgeon) that the needlemember 112 is moving such that there are clicks generated via the spring151. Continuing with the actuation of the present invention, whenproximal end 132 encounters latch 174 d, such latch rotates clockwise(as sloped surface 175 is pushed upward by proximal end 132) to allowentry of proximal member 130. It will be appreciated that release bar176 is biased upward by vertical spring 177, which biases latches 174 dand 174 e toward counter clockwise rotation toward their originalposition when they are rotated clockwise. Proximal end 132 is fedthrough sliding shaft 122 of housing assembly 150, and advancedproximately until it reaches distal end 155 of retraction slide 166,which is operatively disposed in a forward position (not shown in FIGS.10 and 11). When proximal end 132 reaches distal end 155 of retractionslide 166, it clicks into place between distal end 155 and latch 174 das latch 174 d closes around the enlarged head thereof. It will beappreciated that when proximal end 132 of proximal member 130 ofgrasping assembly 116 reaches distal end 155 of retraction slide 166,the radially enlarged head 117 of proximal member 113 of needle member112 interfaces to sliding shaft 122 of handle assembly 150, and alsosnaps into place between latch member 174 e and sliding shaft 122. Inthis manner, both the inner grasping assembly 116 and outer needlemember 112 are positioned and operatively coupled to handle assembly 150for independent control thereof.

In operation button 194 is depressed by a user (e.g., a surgeon),causing as shown in FIG. 21, push button spring 205 to compress allowingsliding shaft 122 to deploy. Retraction slide 166 may then be pulledproximally against the bias of spring 168 and this motion pulls arms124, 126 of grasping assembly 116 fully into needle member 112 to exposedistal tip 118 as shown in FIGS. 3 and 4. At this point, the device isarmed, and the distal tip 118 is advanced into the patient to a surgicalsite. Once the surgical site is reached, button 194 is depressed, andspring 168 pulls slide 166 back to the forward position and to theadvanced open configuration of the arms 124, 126 in FIGS. 1 and 2.Rotation hub 154 may be utilized to rotate grasping assembly 116 andelongated needle member 112 as needed independent of housing assembly150, and the entire assembly may additionally be manipulated by thesurgeon as needed to establish a desired orientation of arms 124, 126about target tissue in the patient. Finally, ratchet 159 is disengaged,and trigger 158 is pulled to distally advance sliding shaft 122, andthus elongated needle member 112 over the grasping assembly 116 to closeand clamp arms 124, 126 about the target tissue. It will be appreciatedthat the grasping arms 124, 126 remain in a fixed longitudinal positionrelative to the patient during closing thereof, which can beadvantageous to the surgeon to avoid unwanted motion or displacement.The arm slide 166 may only be actuated when the trigger 158 is fullyclosed and each mechanism is separate.

Once the elongated needle member 112 is removed from the patient,release switch 175 is operated to vertically raise release bar 176,which vertically raises latches 174 d and 174 e to provide clearance forremoval of disposable needle assembly 110 through aperture 153. A newdisposable assembly can subsequently be used with the reusable handleassembly 150. Other end effectors of the disposable assembly may be usedsuch as scissors, grabbers, clasps, staplers, needle holders,cauterizers and other known end effectors. If graspers are chosen thegraspers may include configurations of babcock, alligator, clutch andbowel style jaws and other known variants. The handle assembly 150 maybe steam sterilized or sterilized through any other suitable andappropriate manner known in the art.

If a disposable assembly is monopolar then the arm includes additionalcomponents. A typical electrosurgical treatment instrument is capable oftreating tissue with the use of heat produced by electrical energy whilecutting, shearing, grasping, or contacting the tissue. Such instrumentsare used to carry out treatments, such as incision, coagulation, and thelike. During such a procedure instrument or device would be equippedwith an active electrode and an inactive, so-called neutral electrode.During the whole duration of the surgery, the neutral electrode iselectrically connected to a large area of the skin of the patient, forexample, to the thigh or the upper arm. The surgical instrumentinterface may further comprise an electrical connector for connectingthe conductor to an external electrosurgical generator. Electricalenergy may be supplied to the surgical instrument by a conventionalelectrosurgical which the user (e.g., surgeon) may activate via a footswitch electrically connected to the electrosurgical generator, causingthe generator to supply electrical energy through a power cord and theconnector to the instrument. Typically a high frequency AC or RF currentmay be employed, with the voltage being dependent on the type and degreeof treatment desired. Voltages may range up to at least 12,000V in somecases, with about 3000V being a typical value, e.g., for coagulation.

As shown in FIGS. 18 (18A and 18B) a monopolar arm 400 includes acontact post 420 having a cage 410 of a plurality of spiral loops. Thecontact post 420 is connected to an electrical source as describedabove. The monopolar arm 400 further includes a monopolar arm slide 430which has an aperture 460 for insertion of the disposable needleassembly 110 or any other disposable assembly capable of activation viaelectrical energy. The monopolar arm 400 further includes monopolarspring 440 and contact plunger 450 so that when the disposable needleassembly 110 is inserted into the aperture 460 it exerts a force on thecontact plunger 450 which compresses contact spring 440 and theelectrical energy is transferred via contact post 420 to the disposableneedle assembly 110.

The present invention allows for a single reusable handle assembly 150into which many types of disposable assemblies may be inserted, locked,actuated and then released for disposable. It will be appreciated thatseparation of the needle and handle assemblies 110, 150 described abovewill also allow the needle assemblies to be melted down and recycled,and the handles to be sterilized and reused. Additionally, it will beappreciated that the access surface area provided by a 5 mm trocar isapproximately 24.6 mm² whereas that provided by the 2.4 mm needle isapproximately 4.5 mm², which represents an 82% reduction in accesssurface area, meaning no stitching or scars, less pain, and a quickerrecovery for the patient. Further, the device may be insertedpercutaneously under direct visualization by the surgeon without the useof a trocar, resulting in a shorter surgery with less tissue trauma andscars.

In one embodiment of the present invention as shown by FIGS. 19A, 19B,19C and 19D, the needle assembly includes a lock hub assembly 500 whichincludes a cap 510 covering an internal lock spring 520 attached to alock pivot 530 which has an upper distal end 532 and lower distal end534 each of which is capable of protruding from the cap 510 and iscapable of moving in one direction. In use, the lock pivot 530 isactuated when the needle assembly 110 is inserted into and then releasedfrom the handle assembly 150. Upon insertion of the needle assembly 110into the handle assembly 150 the lock pivot 530 rotates such the upperdistal end 522 which was protruding from the cap 510 now resides withinthe cap 510. Upon release from the handle assembly 150 the lock pivot530 further rotates but is stopped by the cap 510 actuating a lock bar540 which locks into a latch 550 within the cap 510. The lower distalend 534 of the lock pivot 530 thus protrudes from the cap 510. In thisposition the disposable needle assembly 110 cannot be reused resultingin a safety feature. The cap 510 is attached to the lock hub assembly500 via at least one, preferably two, apertures 562, 564 in the cap 510which attach to a corresponding male member 566, 568 located within thelock hub assembly 500.

The inventive surgical device includes a trigger 158 design in which thepistol grip style has a fixed palm grip and pivoting finger actuatedtrigger such that the trigger may wrap around the middle and ring fingerfor use with smaller hands whereas the surgeon with larger hands maygrip the outer surface of the wrap around trigger 158. In someembodiments of the trigger 158 finger indents may be provided. Thetrigger 158 in use may thus be used by either right handed surgeons andleft handed surgeons. Further, in use the inventive device is capable ofbeing operated single-handedly, with the exception of loading andreleasing the disposable assemblies.

Further, the inventive device has the advantages of an unloaded handlehaving a trigger and arming slide locked in position ready to accept newassemblies such as a needle assembly having different end effectors. Thedisposable assembly may only be released in a safe position with forinstance if using a grasper, fully closed jaws it is anticipated thatsuch a release switch mechanism to be useful for a minimum of 1000cycles.

Further safety features include the arm slide 166 extending from theback of the handle assembly 150 which must be pulled forward with theuser's for instance thumb and index finger by a gripping surface toretract for instance the grasping arms or jaws completely into thedisposable needle member 112 and fully expose the needle tip 118. In usethe user's nominal arming stroke may be about 0.620. Upon completearming the arm slide 166 actuation a latch mechanism which automaticallylocks the device in the armed position. A red visible indicator showsthat the needle assembly 110 is armed and that the sharp needle tip 118is exposed. A button located toward the rear of the left side of thehandle assembly 150 is to be depressed to spring return the needleassembly 110 to the safe position with the needle tip 188 retractedwithin the elongated needle member 112. In one embodiment a nominalreturn spring load at the armed position is capable of driving thegrasper arms 124, 126 out of the needle assembly 110 and is 2.4 poundsof weight or force. It is anticipated that such an arming mechanism tobe useful for a minimum of 1000 cycles.

Another safety feature of the present invention is the rotation hub 154which may include with light resistance to prevent an inadvertentrotation of the grasping assembly 116. In use the rotation hub 154 has atactile resistance and audible clicks heard by the user to indicate therotations. There is a range of continuous rotation in both directions ofthe rotation hub 154 allowing the user ambidextrous operation of allfunctions during surgery except there is a lock during insertion andrelease of the assembly. The rotation lock is actuated during triggeractuation so as to allow rotational manipulation of grasped tissuewithout the need to manually restrain the rotation hub 154.

Yet another safety feature of the present invention includes the trigger158 actuation which requires force to overcome the primary return spring164 to advance needle tip 118 over axially fixed graspers 124, 126. Inone embodiment of the present invention the nominal needle actuationstroke from the safe position to the end effector fully open position is0.690. In one embodiment of the present invention a complete springreturn of trigger and needle is required for the needle assembly 110with a range of nominal return spring load at the safe position of about1.3 pounds. It is anticipated that such a trigger 158 actuationmechanism may be useful for a minimum of 7500 cycles.

A further safety feature of the present invention includes a ratchetswitch 157 or ratchet mechanism 159 which may prevent the trigger 158and needle tip 118 return throughout the full actuation and closing ofthe graspers 124, 126. The ratchet 159 in use may have audible andtactile clicks during actuation. The ratchet 159 may have a minimum offor instance a range of about three (3) to about ten (10) lock positionsthroughout the full graspers 124, 126 closure stroke. The final ratchet159 position may correspond with the fully closed grasping assembly 116in a safe position. In one embodiment of the present invention, aratchet switch 157 will allow the ratchet 159 to be turned on and off todisengaged the ratchet 159 and allow free opening of the graspingassembly 116, or any other assembly with other end effectors, uponmanual release of the trigger 158 by the user. The ratchet switch 157may reside on both sides of the handle assembly 150 and thus may beactuated with the thumb of the user. In one embodiment of the presentinvention the up switch position of the ratchet switch 157 correspondswith the ratchet mode while the down position corresponds to the freemode. A ratchet spring 169 will drive the ratchet switch 157 to eitherits final ratchet position or free position so as to prevent the ratchetswitch 157 from residing in an intermediate position. Such ratchetswitch 157 actuation may have an audible and tactile click as a furthersafety feature for the user. In one embodiment of the present inventiona temporary ratchet release trigger may reside forward of the maintrigger 158 and may be actuated by the index finger of the user. Such atemporary release trigger will allow the ratchet 159 to be released whenthe release trigger is squeezed during the time in use when the deviceis in the ratchet 159 mode. Such an embodiment may have a spring returnand will reengage the ratchet 159 when the temporary release trigger isreleased.

It is anticipated that the life of the handle assembly 150 may exceedmore than 350 surgical procedures and corresponding autoclave cycles.The snap-in insertion and release of loading units causes minimalabrasion, and is anticipated to be useful for a minimum of 1,000 cycles.

Further, the handle assembly 150 has the advantage of being configuredto receive multiple needle assemblies of varying diameters. For instancethe handle assembly may receive and lock a needle assembly having a 5 mmdiameter, a 10 mm diameter or other variants. Thus the handle assembly150 has a universal use with many disposable needle assemblies and evenother assemblies without needles.

The following benefits, structure, and advantages are also contemplatedby the present invention: reduced surgical time resulting in reducedtrauma to the patient and possibly less scarring, easier handling of thedevice by the user via the more tactile and sturdier handle assembly 150which handle assembly 150 is capable of multiple types of disposableassemblies, and other benefits.

The methods and systems of the present invention, as described above andshown in the drawings, provide for minimally invasive surgicalassemblies with superior properties including ease of assembly, use andoperation. While the apparatus and methods of the subject invention havebeen shown and described with reference to preferred embodiments, thoseskilled in the art will readily appreciate that changes and/ormodifications may be made thereto without departing from the spirit andscope of the subject invention.

REFERENCE NUMERALS

-   -   100 surgical device    -   110 disposable needle assembly    -   112 elongated needle member    -   113 lumen    -   113 proximal member of needle member    -   114 needle hub    -   114 a proximal portion of hub    -   114 b distal portion of hub    -   115 proximal head    -   116 grasping assembly    -   117 radially enlarged head (of proximal member 113 of needle        member 112)    -   118 sharpened distal tip portion    -   119 shaft    -   120 lumen    -   121 intermediary member    -   122 sliding shaft    -   124 grasper upper arm    -   126 grasper lower arm    -   128 grasper shaft    -   130 proximal member    -   132 proximal end    -   150 reusable handle assembly    -   151 rotation spring    -   152 housing    -   153 aperture    -   154 rotation hub    -   155 distal end (of slide 166)    -   156 proximal handle member    -   157 ratchet switch    -   158 trigger    -   159 ratchet    -   160 drive link    -   161 switch shaft    -   162 crank assembly    -   163 switch spring lever    -   164 primary return spring    -   165 switch link    -   166 arm slide (of retraction slide 166)    -   167 switch spring    -   168 secondary return spring    -   169 ratchet spring    -   170 release lever    -   171 release spring    -   174 a, 174 b, 174 c latches on latch assembly 172    -   175 release switch    -   176 release bar    -   177 vertical spring    -   178, 180, 182 horizontal grooves    -   179 guide box    -   181 edge (of retraction slide 166)    -   184, 186, 188 respective pins    -   190, 192 vertical grooves    -   191, 193 pins    -   194 Button    -   194 a rim (of button 194)    -   195 groove    -   197 secondary groove    -   200 push button assembly    -   201 button (of button assembly 200)    -   202, 204 flanges    -   205 push button spring    -   206 cutout    -   208 outer surface (of button 201)    -   211 side surface (of button 201)    -   210 inner surface (of hub 114)    -   310 disposable needle assembly    -   319 shaft    -   314 hub assembly    -   319 shaft    -   330 proximal inner shaft    -   335 radially enlarged rim (of shaft 330)    -   340 trigger lock    -   345 trigger lock link    -   350 rotational lock    -   360 cage right    -   361 cage left    -   400 monopolar arm    -   410 contact cage    -   420 contact post    -   430 monopolar slide    -   440 contact spring    -   450 contact plunger    -   460 aperture

What is claimed is:
 1. An apparatus to deploy a disposable needleassembly of a surgical device, the apparatus comprising: a disposableneedle assembly, a reusable handle assembly, and a retraction slide,wherein the disposable needle assembly is configured to be inserted intothe reusable handle assembly, the disposable needle assembly including aneedle member having a sharpened distal tip, a needle shaft with aninner surface that defines a needle shaft lumen, and a needle hubdetachably coupled to the handle assembly and defining a needle hublumen, wherein the needle shaft is extendable through the needle hublumen and into an interior of the handle assembly via a sliding shaft inthe interior of the handle assembly, the disposable needle assembly alsohaving a grasping assembly that longitudinally translates through theneedle shaft lumen, the grasping assembly having arms coupled to orintegrally formed with an arm shaft, the reusable handle assemblyincluding a crank assembly for coupling a trigger to the sliding shaftfor actuating the needle shaft, a primary return spring for biasing thesliding shaft proximally and the trigger distally so as to extend thearms of the grasping assembly in a manner that spreads the arms apartfrom each other at a location beyond the sharpened distal tip of theneedle member, wherein the disposable needle assembly and the graspingassembly are configured and arranged to be selectively manipulated withthe reusable handle assembly relative to each other and relative to theneedle hub and relative to the reusable handle assembly, and wherein theretraction slide is configured and arranged to be manipulated toselectively longitudinally translate a proximal member within the needleshaft lumen and within the sliding shaft, the retraction slideinterfacing with a proximal end of the proximal member to translate thearm shaft and the arms of the grasping assembly relative to the needlemember, the proximal member being configured and arranged to define aninterference fit with an interior surface of the needle shaft lumen andan interior surface of the needle hub lumen to rotatably fix the needlemember to the grasping assembly.
 2. The apparatus of claim 1, whereinthe retraction slide has a rim that leaves a primary groove of theretraction slide to ride along an edge of the retraction slide, theretraction slide being configured to retract against bias of a springuntil the rim reaches a secondary groove of the retraction slide wherethe rim snaps into the secondary groove, in response to the retraction,the arms of the grasping assembly are configured and arranged to bepulled fully into the needle member of the disposable needle assembly toexpose a distal tip of the needle member, and in response to the arms ofthe grasping assembly being pulled fully into the needle member, thedistal tip of a needle member advances to a surgical site.
 3. Theapparatus of claim 2, further comprising a push button assemblyconfigured and adapted to be radially translated between radially inwardand outward positions so as to prevent longitudinal translation of theshaft of the grasping assembly relative to the needle member as the pushbutton assembly is operatively disposed in the radially outwardposition, which also constitutes an unpressed condition, by causingflanges to interface with the shaft of the grasping assembly.
 4. Theapparatus of claim 3, wherein the needle hub is detachably coupled andis longitudinally fixed to the handle assembly, the push button assemblyincluding a push button that becomes stuck in position in response tothe push button being depressed into the radially inward position sothat the push button cannot be moved radially outward because surfacesof the push button become wedged within the needle hub from aninterference fit that arises between a side surface of the push buttonand an inner surface of the needle hub.
 5. A method of deploying adisposable needle assembly of a surgical device, the method comprisingthe steps of: inserting a disposable needle assembly into a reusablehandle assembly, the disposable needle assembly including a needlemember having a sharpened distal tip, a needle shaft with an innersurface that defines a needle shaft lumen, and a needle hub detachablycoupled to the handle assembly and defining a needle hub lumen, theneedle shaft is extendable through the needle hub lumen and into aninterior of the handle assembly via a sliding shaft in the interior ofthe handle assembly, the disposable needle assembly also having agrasping assembly that longitudinally translates through the needleshaft lumen, the grasping assembly having arms coupled to or integrallyformed with an arm shaft, the reusable handle assembly including a crankassembly for coupling a trigger to the sliding shaft for actuating theneedle shaft, a primary return spring for biasing the sliding shaftproximally and the trigger distally so as to extend the arms of thegrasping assembly in a manner that spreads the arms apart from eachother at a location beyond the sharpened distal tip of the needlemember; selectively manipulating the disposable needle assembly and thegrasping assembly with the reusable handle assembly relative to eachother and relative to the needle hub and relative to the reusable handleassembly; and manipulating a retraction slide to selectivelylongitudinally translate a proximal member within the needle shaft lumenand within the sliding shaft, the retraction slide interfacing with aproximal end of the proximal member to translate the arm shaft and thearms of the grasping assembly relative to the needle member, theproximal member being configured and arranged to define an interferencefit with an interior surface of the needle shaft lumen and an interiorsurface of the needle hub lumen to rotatably fix the needle member tothe grasping assembly.
 6. The method of claim 5, further comprising:preventing the grasping assembly from translating distally relative tothe disposable needle assembly as the inserting of the disposable needleassembly into the handle assembly is taking place; and after the step ofinserting, depressing a button assembly to allow the distal translationof the grasping assembly to occur.
 7. The method of claim 6, wherein thedepressing of the button assembly prevents longitudinally locking ofcomponents of the needle assembly.
 8. The method of claim 5, furthercomprising: causing a rim to leave a primary groove of the retractionslide to ride along an edge of the retraction slide; retracting theretraction slide by pulling the retraction slide against bias of aspring until the rim reaches a secondary groove of the retraction slidewhere the rim snaps into the secondary groove; in response to theretracting, pulling arms of the grasping assembly fully into the needlemember of the disposable needle assembly to expose a distal tip of theneedle member; and in response to the pulling of the arms of thegrasping assembly fully into the needle member, advancing the distal tipof a needle member to a surgical site.
 9. The method of claim 8, furthercomprising pulling the retraction slide back under spring bias to aposition that corresponds to an advance open configuration of the armsof the grasping assembly.
 10. The method of claim 8, further comprisinga housing that contains the retraction slide, the rim and the graspingassembly; and rotating the grasping assembly and the needle member witha rotation hub independent of the housing.
 11. The method of claim 8,further comprising disengaging a ratchet; and pulling the trigger todistally advance the sliding shaft, and thus needle assembly, over thegrasping assembly to close and clamp the arms at the surgical site. 12.The method of claim 11, further comprising keeping the arms in a fixedlongitudinal position relative to the surgical site during closing ofsaid arms at the surgical site.
 13. The method of claim 8, furthercomprising removing the needle member; operating a lever to release arelease bar that vertically raises latches to increase an amount ofclearance available so that the clearance becomes sufficient for removalof disposable needle assembly through an aperture; and pulling theneedle member distally through the aperture.
 14. The method of claim 8,further comprising a push button assembly configured and adapted to beradially translated between radially inward and outward positions so asto prevent longitudinal translation of the shaft of the graspingassembly relative to the needle member as the push button assembly isoperatively disposed in the radially outward position, which alsoconstitutes an unpressed condition, by causing flanges to interface withthe shaft of the grasping assembly.
 15. The method of claim 14, whereinthe needle hub detachably couples and is longitudinally fixed to thehandle assembly, the push button assembly including a push button thatbecomes stuck in position in response to the push button being depressedinto the radially inward position so that the push button cannot bemoved radially outward because surfaces of the push button become wedgedwithin the needle hub from an interference fit that arises between aside surface of the push button and an inner surface of the needle hub.16. The method of claim 15, wherein in response to the push button beingdepressed into the radially inward position, the push button extendsinto the needle hub and defines a passage for longitudinal translationof the shaft of the grasping assembly and defines an arcuate outersurface that is radially aligned with or radially inward of an outersurface of the needle hub.
 17. The method of claim 5, wherein the needlemember has a shaft that extends through proximal and distal portions ofthe needle hub and couples to the proximal member that has a proximalhead of enlarged diameter that interfaces to the sliding shaft of thehandle assembly, the sliding shaft is coupled to the trigger of thehandle assembly in a manner enabling the trigger to retract so as todistally and longitudinally translate the sliding shaft of handleassembly and the proximal member of the needle member relative to thegrasping assembly.